Senior HPAPI Process Development Scientist

Piramal Pharma Ltd; Riverview (MI); On-site; USD 95,000 - 140,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan, is seeking a qualified Process Development Scientist to join our Process Development team. The PD Scientist is responsible for the development of current and new manufacturing processes.

Education/experience requirements include a PhD in Organic or Medicinal Chemistry with up to four years of relevant work, or MS with up to eight years, or BS with up to twelve years.

Qualifications

• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Self-motivated, creative, and independent.
• Ability to direct projects covering a variety of chemical compounds including high potent APIs.
• Familiarity with cGMP, plant safety, and EPA requirements.

Responsibilities

• Develop, conduct, and/or manage the process development of current and new synthetic/process pathways including routine analytical testing to monitor process progress (HPLC, NMR, XRPD, GC-HS, KF, etc.).
• Handling of highly potent compounds and experience in synthesis and handling of Linker-Payloads is highly desirable.
• Scale-up preparative HPLC purification and lyophilization of intermediates and final products.
• Maintain communications with clients and ensure their requirements are met.
• Manage/support the production of new (HP)APIs. Ensure adequate supplies of process materials and operation equipment are available.
• Ensure product shipments meet regulatory requirements.
• Write progress reports and provide technical support in meetings regarding current API production and new API process development.
• Ensure approved processes are carried out according to cGMP guidelines and documented.
• Keep QA/QC departments updated on project/client requirements and schedules.

Skills

Analytical thinking

Communication

Project leadership

cGMP knowledge

Education

PhD in Organic or Medicinal Chemistry

MS in Organic or Medicinal Chemistry

BS in Organic or Medicinal Chemistry

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan, is seeking a qualified Process Development Scientist to join our Process Development team. The PD Scientist is responsible for the development of current and new manufacturing processes.

Education/experience requirements include a PhD in Organic or Medicinal Chemistry with up to four years of relevant work, or MS with up to eight years, or BS with up to twelve years.